AL Solutions are partnered with a large Life Sciences Consultancy who are searching for a Regulatory Affairs Consultant to support with submissions to the local authorities in Azerbaijan.
Key Responsibilities:
- Regulatory Strategy Development: Develop and implement regulatory strategies for product submissions, ensuring alignment with company goals and regulatory requirements.
- Regulatory Submissions: Prepare, review, and submit regulatory documents, including INDs, NDAs, BLAs, MAAs, and other relevant submissions to regulatory authorities.
- Compliance Management: Ensure all regulatory activities comply with applicable laws, regulations, and guidelines. Maintain up-to-date knowledge of regulatory requirements and industry standards.
- Cross-Functional Collaboration: Work closely with R&D, Clinical, Quality, and other departments to gather necessary information for regulatory submissions and to ensure alignment with regulatory strategies.
- Regulatory Intelligence: Monitor and analyze regulatory changes and trends. Provide regulatory intelligence and guidance to internal teams to support product development and commercialization.
- Project Management: Manage multiple regulatory projects simultaneously, ensuring timely and accurate submissions. Track project timelines and deliverables, and communicate progress to stakeholders.
- Regulatory Audits and Inspections: Support regulatory audits and inspections. Prepare and coordinate responses to regulatory inquiries and deficiencies.
- Training and Mentorship: Provide training and mentorship to junior regulatory staff and other team members on regulatory requirements and best practices.
